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FDA 510(k)

CORTISOL RIA KIT

K-Number: K822892 · 1982-11-01

ApplicantAntibodies, Inc.
Decision Date1982-11-01
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Antibodies, Inc.. It received FDA 510(k) clearance on 1982-11-01 under 510(k) number K822892. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTISOL RIA KIT?

CORTISOL RIA KIT is a medical device that received FDA 510(k) clearance on 1982-11-01. The listed applicant is Antibodies, Inc.. The 510(k) number is K822892.

When did CORTISOL RIA KIT receive FDA 510(k) clearance?

CORTISOL RIA KIT received FDA 510(k) clearance on 1982-11-01, under 510(k) number K822892.

Who is the listed applicant for CORTISOL RIA KIT?

The FDA 510(k) record lists Antibodies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTISOL RIA KIT?

The FDA product code for CORTISOL RIA KIT is CGR.

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Other records listing Antibodies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K890774GIARDEIA(TM)K843590DETECT-A-STREPK812749ULTRA-DIGK812314CRITHIDNA ANTI-DNA TEST KITK802877AMIKACIN RIA KITK800743TOBRAMYCIN RIA KIT

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Related Devices (Code: CGR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.K223038Access CortisolBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K062626CORTISOL ELISAIbl-Hamburg GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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